Chang Chun-Ming, Wang Po-Fang, Wang Yu-Tzu
National Center for Instrumentation Research, National Institutes of Applied Research, Hsinchu, Taiwan.
Craniofacial Research Center, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.
Front Bioeng Biotechnol. 2025 Aug 20;13:1598975. doi: 10.3389/fbioe.2025.1598975. eCollection 2025.
Patients with hemifacial microsomia exhibit varying degrees of mandibular asymmetry. The commercial plates used during bilateral sagittal split osteotomy (BSSO) surgery are often not tailored to individual patients and may lack sufficient fixation stability, increasing the risk of mandibular relapse. This study proposes a patient-specific plate design by collecting CT images of 30 cases of hemifacial microsomia to statistically analyze mandibular asymmetry.
The design process integrates topology and parameter optimization analysis to develop the plate (TOPO plate), aiming for a lightweight structure with enhanced fixation stability. The structural strength and fixation stability of the TOPO plate were verified through static and dynamic four-point bending tests, as well as biomechanical testing, ensuring compliance with clinical requirements and regulatory approval for market release.
The TOPO plate features an asymmetrical design tailored to patient's specific anatomy. In static/dynamic four-point bending tests, the structural strength of the TOPO plate exceeded that of commercial plates, with average proof loads of 326.9N for the right side and 389.85N for the left side. Biomechanical analysis and testing confirmed that the TOPO plate effectively limits the displacement of the mandibular segment (average 0.45mm), providing favorable fixation stability and thereby reducing the risk of relapse.
In summary, the TOPO plate is applicable for most patients with hemifacial microsomia, meeting the biomechanical requirements of the mandible and complying with market conditions. This patient-specific approach promises improved outcomes in mandibular fixation stability.
半侧颜面短小畸形患者表现出不同程度的下颌骨不对称。双侧矢状劈开截骨术（BSSO）手术中使用的商用钢板通常未针对个体患者进行定制，可能缺乏足够的固定稳定性，增加了下颌骨复发的风险。本研究通过收集30例半侧颜面短小畸形患者的CT图像，提出了一种针对患者的钢板设计，以对下颌骨不对称进行统计分析。
设计过程整合拓扑和参数优化分析以开发该钢板（TOPO钢板），目标是实现具有增强固定稳定性的轻质结构。通过静态和动态四点弯曲试验以及生物力学测试验证了TOPO钢板的结构强度和固定稳定性，确保符合临床要求并获得市场发布的监管批准。
TOPO钢板具有针对患者特定解剖结构定制的不对称设计。在静态/动态四点弯曲试验中，TOPO钢板的结构强度超过了商用钢板，右侧平均屈服载荷为326.9N，左侧为389.85N。生物力学分析和测试证实，TOPO钢板有效地限制了下颌骨节段的位移（平均0.45mm），提供了良好的固定稳定性，从而降低了复发风险。
总之，TOPO钢板适用于大多数半侧颜面短小畸形患者，满足下颌骨的生物力学要求并符合市场条件。这种针对患者的方法有望改善下颌骨固定稳定性的效果。
